CLASS II Device recall · Reported 1 Jan 2014 · FDA Enforcement Report

Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System recalled

Ziehm Imaging is recalling Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System, distributed nationwide in the US. The recall was initiated on 21 Nov 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes50104 50694 50704 50714 50812 50875 50105 50695 50705 50785 50813 50901 50106 50696 50706 50786 50815 50902 50107 50697 50707 50802 50817 50925 50108 50698 50708 50803 50818 50926 50109 50699 50709 50804 50819 50927 50653 50700 50710 50805 50820 50937 50663 50701 50711 50808 50872 50939 50671 50702 50712 50810 50873 50693 50703 50713 50811 50874

Quantity recalled58 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0563-2014
FDA event ID: 66976
Recalling firm: Ziehm Imaging, Orlando, FL
Classification: Class II
Status: Terminated
Recall initiated: 21 Nov 2013
FDA classified: 24 Dec 2013
Reported: 1 Jan 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

21 Nov 2013	Recall initiated by company
24 Dec 2013	Classified by FDA	+33 days
1 Jan 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.

Product as listed by the FDA

Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging

Where it was distributed

USA (Nationwide) Distribution including the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MT, MA, MD, MI, MN, MN, MO,MS, NC ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Hawaii.

Nationwide Alaska Alabama Arizona California Colorado Connecticut Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan

Questions about this recall

Is Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System recalled?

Yes. Ziehm Imaging recalled Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System on 21 Nov 2013. The recall is Class II and its status is Terminated. Recall number Z-0563-2014.

Why was it recalled?

Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.

Which lots are affected?

50104 50694 50704 50714 50812 50875 50105 50695 50705 50785 50813 50901 50106 50696 50706 50786 50815 50902 50107 50697 50707 50802 50817 50925 50108 50698 50708 50803 50818 50926 50109 50699 50709 50804 50819 50927 50653 50700 50710 50805 50820 50937 50663 50701 50711 50808 50872 50939 50671 50702 50712 50810 50873 50693 50703 50713 50811 50874

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Ziehm Imaging

All 14

Reported	Class	Recall	Company	Reason	Where
24 May 2017Device	CLASS II	solo FD Mobile Fluoroscopic C-arm recalled by Ziehm Imaging	Ziehm Imaging	Processing Deviation	CA, FL
31 Aug 2016Device	CLASS II	Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging recalled	Ziehm Imaging	Device Malfunction	17 states
31 Aug 2016Device	CLASS II	Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging recalled	Ziehm Imaging	Device Malfunction	17 states
31 Aug 2016Device	CLASS II	Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging recalled	Ziehm Imaging	Device Malfunction	17 states
31 Aug 2016Device	CLASS II	Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging recalled	Ziehm Imaging	Device Malfunction	17 states

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